G/SPS/N/BRA/2073  
 
22 September 2022  
(22-7114) Page: 1/2 
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
  NOTIFICATION  
1. Notifying Member:  BRAZIL  
If applicable, name of local government involved:   
2. Agency responsible:  The Brazilian Health Regulatory Agency (ANVISA)  
3. Products covered (provide tariff item number(s) as specified in national 
schedules deposited with the WTO; ICS numbers should be provided in addition, 
where applicable):  Food technology (ICS code(s): 67)  
4. Regions or countries likely to be affected, to the extent relevant or practicable : 
[X] All trading partners   
[ ] Specific regions or countries:   
5. Title of the notified document:  Draft Resolution number 1113, 6 September 2022 . 
Language(s):  Portuguese . Number of pages:  11 
Draft: 
http://antigo.anvisa.gov.br/documents/10181/6485886/consulta_publica_1113_2022+GE
REG+%281%29.pdf /bf4855e5 -6a5a-4551-8c8b-2b3dacba1094  
Comment form: https://pesquisa.anvisa.gov.br/index.php/463557?lang=pt -BR 
6. Description of content:  This draft resolution contains provisions on the regularization of 
food and packaging under the competence of the National Health Surveillance System 
(SNVS) intended for supply in the national territory . 
In workshops held with health surveillance, the low effectivene ss of current regulatory 
procedures for food regularization was identified with the following consequences: lack of 
access to information about regularized products; lack of clarity of regulation; difficulties 
with food categorization; lack of definition o f how this risk is understood; insufficient 
technical information resulting in inadequate controls, especially for higher risk products; 
insufficient operational capacity of analytical laboratories; forms of regularization in 
insufficient quantity (registr ation or exemption from registration), considering the 
variability of existing foods and their different levels of risk; regulatory gaps, among 
others. Thus, given the whole scenario found in the analysis of the problem, among other 
measures, the need for regulatory changes to solve the main problem is pointed out.  
This regulation will be also notified to the TBT Committee.  
7. Objective and rationale: [X]  food safety, [  ] animal health, [  ] plant protection, 
[ ] protect humans from animal/plant pest or dis ease, [  ] protect territory from 
other damage from pests.   
8. Is there a relevant international standard? If so, identify the standard:  
[ ] Codex Alimentarius Commission (e.g.  title or serial number of Codex 
standard or related text) :  
[ ] World Organization for Animal Health (OIE) (e.g.  Terrestrial or Aquatic 
Animal Health Code, chapter number) :  G/SPS/N/BRA/2073  
 
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  [ ] International Plant Protection Convention (e.g.  ISPM number) :  
[X] None  
Does this proposed regulation conform to the relevant international st andard?  
[ ] Yes   [  ] No 
If no, describe, whenever possible, how and why it deviates from the 
international standard:   
9. Other relevant documents and language(s) in which these are available:    
10. Proposed date of adoption (dd/mm/yy) : To be determined after the end of the 
consultation period.  
Proposed date of publication (dd/mm/yy) : To be determined after the end of the 
consultation period.  
11. Proposed date of entry into force: [  ] Six months from date of publication , and/or  
(dd/mm/yy) : To be determined after the end of the consultation period.  
[ ] Trade facilitating measure   
12. Final date for comments: [  ] Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : 13 December 2022  
Agency or authority designated to handle comments: [  ] National Notification 
Authority, [X]  National Enquiry Point. Address, fax number and e -mail address (if 
available) of other body:   
Assessoria de Assuntos Internacionais – AINTE  
International Affairs Office  
Agência Naciona l de Vigilância Sanitária – Anvisa  
Brazilian Health Regulatory Agency  
Tel: +(55 61) 3462 5402/5404/5406  
E-mail: rel@anvisa.gov.br  
13. Text(s) available from: [  ] National Notification Authority, [X]  National Enquiry 
Point. Address, fax number and e -mail address (if available) of other body:   
Assessoria de Assuntos Internacionais – AINTE  
International Affairs Office  
Agência Nacional de Vigilância Sanitária – Anvisa  
Brazilian Health Regulatory Agency  
Tel: +(55 61) 3462 5402/5404/5406  
E-mail: rel@anvisa.gov.br